Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus
|ClinicalTrials.gov Identifier: NCT01709474|
Recruitment Status : Terminated (Due to slow enrollment)
First Posted : October 18, 2012
Results First Posted : December 3, 2015
Last Update Posted : December 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Vitamin D3 6000 IU Drug: Vitamin D3 400 IU||Phase 2|
This is a multi-center, phase II, 18-week, two arm, unblinded randomized clinical trial.
Seventy-eight pediatric subjects with SLE and 25(OH)D levels ≤ 20 ng/mL will be randomized in a 1:1 ratio to receive either standard-dose (400 IU/day) or high-dose (6,000 IU/day) vitamin D3 for 18 weeks based upon weight at baseline. Subjects randomized to the high-dose vitamin D3 treatment arm will receive 6,000 IU per day from baseline until the subject's vitamin D levels reach ≥ 40 ng/mL at which point the vitamin D3 dose will be reduced to 4,000 IU per day. Subjects randomized to the high-dose treatment arm weighing < 40 kg will receive supplementation five days per week and all other subjects will receive supplementation seven days a week.
In addition to the baseline, and weeks 6, 12, and 18 visits, subjects randomized to the high-dose treatment arm will return at Weeks 3 and 9 to assess for symptoms of vitamin D toxicity. If a subject in the high-dose arm is found to exhibit evidence of vitamin D toxicity at the week 12 visit, he/she will be asked to return to their clinical research site for an additional vitamin D toxicity assessment at week 15. Study personnel will record each subject's interval history, assess adverse events, disease activity, and collect samples for safety and mechanistic assessments.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)|
|Study Start Date :||June 2013|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
Experimental: Vitamin D3 6000 IU
6000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose is reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week.
Drug: Vitamin D3 6000 IU
Subjects will receive 6,000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose will be reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week.
Active Comparator: Vitamin D3 400 IU
400 IU/day of vitamin D3 by mouth daily.
Drug: Vitamin D3 400 IU
Subjects will receive 400 IU/day of vitamin D3 daily by mouth.
- Change in Average IFN Module Expression Level [ Time Frame: Baseline to Week 18 ]No mechanistic analyses were performed due to recruitment feasibility issues.
- Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3 [ Time Frame: Baseline to 18 Weeks ]Adverse event grading based on National Cancer Institute— Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709474
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Lucile Packard Children's Hospital, Stanford University|
|Palo Alto, California, United States, 94304|
|UCSF School of Medicine|
|San Francisco, California, United States, 94143|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|New York, New York, United States, 10032|
|University of Rochester|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Children's Medical Center of Dallas|
|Dallas, Texas, United States, 75235|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98101|
|Study Chair:||Jon M Burnham, MD, MSCE||University of Pennsylvania|
|Study Chair:||Emily Von Scheven, MD, MAS||University of California, San Francisco|